eTMF & Regulatory Operations Specialist

Evolution Research Group; United States; On-site; USD 60,000 - 85,000; Full time

Job summary

Evolution Research Group is seeking a TMF Specialist to manage, review, and approve site-level documentation in the eTMF, ensuring timely filing and audit readiness across studies.

You will collaborate with Regulatory Operations and internal teams, maintain EDL, support TMF audits, and contribute to process improvements while upholding GCP/ICH standards. This role requires at least 1 year in clinical research or regulatory operations and experience with eTMF systems like Veeva Vault.

Qualifications

• Bachelor’s degree in biological sciences or related field.
• At least 1 year of experience in clinical research, document management, or regulatory operations.
• Experience with electronic document management systems and eTMF platforms (e.g., Veeva Vault) preferred.

Responsibilities

• Review, process, and approve TMF documents in the electronic TMF (eTMF).
• Validate document quality and version control before approval.
• Collaborate with internal teams to resolve discrepancies and ensure timely filing.
• Maintain complete, inspection-ready TMF throughout the study lifecycle.
• Update and monitor the Expected Documents List (EDL) per sponsor and regulatory standards.
• Support TMF audits and audit responses; organize documentation.

Skills

GCP knowledge

ICH guidelines

eTMF systems (Veeva)

Document management

Regulatory operations

Attention to detail

Communication skills

MS Office

Education

Bachelor's degree in biological sciences

Tools

Veeva Vault

Microsoft Office

Job description

Evolution Research Group is seeking a TMF Specialist to manage, review, and approve site-level documentation in the eTMF, ensuring timely filing and audit readiness across studies.

You will collaborate with Regulatory Operations and internal teams, maintain EDL, support TMF audits, and contribute to process improvements while upholding GCP/ICH standards. This role requires at least 1 year in clinical research or regulatory operations and experience with eTMF systems like Veeva Vault.